Two Thalidomide Disasters

The second one hurt many more people than the first one.

Another myth is that, at least in the thalidomide era, the FDA usually uncovered problems with new drugs before they became obvious. The truth is the FDA learned about the problems with thalidomide at the same time as the public. It was only after the tragedy was exposed in Germany and Australia that the FDA became aware of the issue, obviating an FDA review.

Another myth is that thalidomide is an awful drug that has been forever banished from the market. In fact, it and some close variants are available and widely used today, though with the guidance that it not be used by pregnant women. The drug is effective in adults for treating several serious diseases, including some skin conditions arising from leprosy and certain cancers, such as multiple myeloma. Bristol Myers Squibb’s Revlimid (lenalidomide), a slightly tweaked version of thalidomide, was the second largest selling drug in the United States in 2019 and it is helping thousands of people. US revenues for Revlimid peaked at $12.9 billion in 2021, the year before its patent expired.

People also commonly think that FDA rules were changed in the wake of thalidomide to give the agency more power to prevent subsequent drug safety problems. But in fact, the main changes to federal law and regulations following the tragedy addressed drug efficacy, i.e., effectiveness, not drug safety. The FDA had been charged with ensuring that new drugs were safe more than two decades before the thalidomide tragedy. No published study we know of shows that drugs today are safer than they were in the thalidomide era, even with the new FDA rules.

This is from Charles L. Hooper and David R. Henderson, “Two Thalidomide Disasters,” Regulation, Winter 2024-2025.

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